Non Small Cell Lung CancerPhase 3ANDROMEDANCT06141070
Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease
A Phase 3 study testing Standard systemic therapy + radiotherapy and Standard systemic therapy in people with Non Small Cell Lung Cancer, run by Vastra Gotaland Region at 6 sites in Sweden.
Trial summary
This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Standard systemic therapy + radiotherapy and Standard systemic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesSweden
- Study dates
- 1 Dec 2023to 1 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening procedures
- Histological or cytological diagnosis of NSCLC
- Stage IV disease with ≤5 metastases (not including primary tumour or mediastinal nodes, N1-N3)
- Patient deemed fit for first line chemoimmunotherapy, immunotherapy or chemotherapy
- Extra-thoracic metastases accessible for stereotactic body radiotherapy (SBRT)
- Thoracic tumour(s) accessible for SBRT or conventional radiotherapy
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- Received no prior systemic treatment or radiation therapy for NSCLC (previous adjuvant systemic therapy is allowed)
- Age > 18 years at time of study entry, no upper age limit
- WHO performance status 0-2
- Adequate normal organ and marrow function Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects.
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Who cannot join
- • Solitary brain lesion or contralateral lung lesion as the only distant metastasis
- Participation in another clinical study with an investigational product during the last 4 weeks
- Patients with EGFR+, ALK+, ROS1+ disease or any other genetic alteration that would result in a TKI based first line treatment (i.e. first line treatment not being chemoimmuno- or immunotherapy)
- Malignant pleural fluid, or ascites (malignant cells or clinical judgement) or excessive fluid hampering radiation according to protocol
- Leptomeningeal disease
- Pulmonary fibrosis making protocol stipulated treatment hazardous (low grade radiologic findings are allowed as assessed by the investigator)
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- Not deemed fit for standard first line systemic therapy
- Second primary residual malignancy. Other malignancy diagnosed and treated > 2 years ago without relapse and deemed to have a low likelihood of relapse is allowed. (Carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin < 2 years are allowed, as is other low-grade malignancy with low likelihood of becoming metastatic or impact on survival e.g. low-grade prostate cancer not in need of treatment)
- Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of systemic therapy
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Recruiting
Dept of Oncology
Gothenburg, 41345
Andreas Hallqvist, andreas.hallqvist@vgregion.se
- Not yet recruiting
Dept of pulmonary medicine
Linköping
Anders Wikström, anders.vikstrom@regionostergotland.se
- Not yet recruiting
Dept of pulmonary medicine
Lund
Maria Planck, Ass. prof., maria.planck@med.lu.se
- Recruiting
Dept of Oncology
Stockholm
Karin Lindberg, PhD, karin.lindberg@ki.se
- Recruiting
Dept. of Oncology
Umeå
Mikael Johansson, Ass. Prof., mikael.b.johansson@umu.se
- Recruiting
Dept. of Oncology
Uppsala
Georg Holgersson, georg.holgersson@akademiska.se
About this study
Official title: Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease - An Open Label Randomized Phase III Trial Comparing Up-front Radiation in Oligometastatic Non-small Cell Lung Cancer (NSCLC) and Systemic Treatment With Systemic Treatment Alone
This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. The systemic treatment consists of chemotherapy/chemoimmunotherapy or immunotherapy and is given according to local practice. During the first 3 months of systemic treatment, aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions. Preferably with SBRT /SRT/SRS but conventional radiotherapy may also be used. After the first three cycles of systemic treatment, the patients are assessed, and after four cycles, they are continuing maintenance therapy if indicated. The patients are followed with radiology every three months.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Standard systemic therapy + radiotherapy, Standard systemic therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard systemic therapy + radiotherapyOther
Combined systemic therapy + radiation
Standard systemic therapyDrug
Chemoimmunotherapy or immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| A, standard systemic therapy | Active comparator | Standard systemic chemoimmunotherapy Receives: Drug: Standard systemic therapy |
| B, Radiotherapy + systemic therapy | Experimental | Standard systemic chemoimmunotherapy and radiation to all known lesions Receives: Other: Standard systemic therapy + radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time to death
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (2)
Progression-free survival (PFS)
Time to progressive disease or death
Measured: From date of randomization until the date of first documented systemic progression or date of death from any cause, whichever came first, assessed up to 60 months
Local control (LC)
Percentage complete, partial remission or stable disease
Measured: At 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141070
- Sponsor's protocol ID
- The ANDROMEDA trial
- Acronym
- ANDROMEDA
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease - An Open Label Randomized Phase III Trial Comparing Up-front Radiation in Oligometastatic Non-small Cell Lung Cancer (NSCLC) and Systemic Treatment With Systemic Treatment Alone
- ClinicalTrials.gov ID
- NCT06141070
- Acronym / sponsor ID
- ANDROMEDA / The ANDROMEDA trial
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. The systemic treatment consists of chemotherapy/chemoimmunotherapy or immunotherapy and is given according to local practice. During the first 3 months of systemic treatment, aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions. Preferably with SBRT /SRT/SRS but conventional radiotherapy may also be used. After the first three cycles of systemic treatment, the patients are assessed, and after four cycles, they are continuing maintenance therapy if indicated. The patients are followed with radiology every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, standard systemic therapy | Active comparator | Drug: Standard systemic therapyStandard systemic chemoimmunotherapy |
| B, Radiotherapy + systemic therapy | Experimental | Other: Standard systemic therapy + radiotherapyStandard systemic chemoimmunotherapy and radiation to all known lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening procedures
Key exclusion criteria (10 listed)
- • Solitary brain lesion or contralateral lung lesion as the only distant metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard systemic therapy + radiotherapyCombined systemic therapy + radiation | Other | B, Radiotherapy + systemic therapy |
| Standard systemic therapyChemoimmunotherapy or immunotherapy | Drug | A, standard systemic therapy |
Primary outcome
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Time to death
2 secondary outcomes
Progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented systemic progression or date of death from any cause, whichever came first, assessed up to 60 months
Local control (LC)
Time frame: At 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard systemic therapy + radiotherapy and Standard systemic therapy in people with Non Small Cell Lung Cancer, run by Vastra Gotaland Region at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Hallqvist (+46313427954, andreas.hallqvist@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.